In 2003, there was a death of a U.S. major league baseball pitcher which was thought to be related to ephedra. The U.S. Food and Drug Administration (FDA) has collected more than 800 reports of serious toxicity, including more than 22 deaths. On February 6, 2004, the FDA issued a rule prohibiting the sale of dietary supplements containing ephedrine alkaloids (ephedra). This rule was issued because supplements with ephedra present a serious risk of illness or injury.

In 2005 this rule was struck down in Utah but reversed again four months later. Ephedra is currently banned throughout the United States. It remains unclear whether ephedra will re-appear on the market, despite serious safety risks, including heart events or death.

Ephedra sinica, a species of ephedra (ma huang), contains ephedrine and pseudoephedrine. Ephedra has been found to stimulate the nervous system, increase airflow into the lungs and constrict blood vessels. In combination with caffeine, ephedra appears to cause weight loss. However, effects of ephedra or ephedrine monotherapy have been mixed. Ephedrine has been widely studied for asthma and low blood pressure. However, quality research of commercial supplements with ephedra is lacking.

Major safety concerns have been associated with ephedra or ephedrine use, including high blood pressure, increased heart rate, nervous system excitation, irregular heartbeat, heart attack, and stroke.

These uses have been tested in humans or animals. Safety and effectiveness have not always been proven. Some of these conditions are potentially serious, and should be evaluated by a qualified healthcare provider.

GRADE *

In human research, ephedra caused weight loss when used in combination with caffeine. The research on ephedra alone is limited and results are mixed. The amounts of ephedra in commercially available products varied widely and numerous adverse effects have been reported. Further research is necessary.

B

Early studies suggest that ephedrine nasal spray may help treat symptoms of nasal allergies. Additional research is needed before a firm conclusion can be made.

C

Ephedra contains the chemicals ephedrine and pseudoephedrine, which are bronchodilators (expand the airways for easier breathing). It has been used and studied to treat asthma and chronic lung diseases in both children and adults. Other treatments, such as inhalers (for example albuterol), are more commonly recommended due to safety concerns with ephedra or ephedrine. Further research is needed.

C

Early research demonstrates mixed findings regarding the effects of ephedra on athletic performance. Further research is needed in this area.

C

Chemicals in ephedra may stimulate the heart, increase heart rate, and raise blood pressure. Ephedrine, a component of ephedra, is sometimes used in hospitals to help control blood pressure. However, the effects of over-the-counter ephedra supplements lack sufficient study. Further research is needed.

C

Limited research shows that ephedra in combination with other herbs commonly used in traditional Chinese medicine (TCM) may be beneficial for infections of the upper respiratory tract (nose, throat, and mouth). Further research of ephedra alone is needed before conclusions can be made.

C

Early research suggests that ephedra may increase sexual arousal in women. Further well-designed research is needed to confirm these results.

C

* Key to grades

A: Strong scientific evidence for this useB: Good scientific evidence for this useC: Unclear scientific evidence for this useD: Fair scientific evidence for this use (it may not work)F: Strong scientific evidence against this use (it likley does not work)

Tradition / Theory
The below uses are based on tradition, scientific theories, or limited research. They often have not been thoroughly tested in humans, and safety and effectiveness have not always been proven. Some of these conditions are potentially serious, and should be evaluated by a qualified healthcare provider. There may be other proposed uses that are not listed below.

Note: The U.S. Federal Government has banned the sale of ephedra since 2004. Ephedra may cause serious adverse effects at any dose, particularly when used with other drugs, such as caffeine. Because of serious safety concerns, ephedra cannot be suggested in any dose.

Traditionally, herbalists have suggested a wide range of doses (8-100 milligrams ephedra by mouth three times daily). Previously, over-the-counter drugs containing ephedra advised taking 12.5-25 milligrams ephedra by mouth every four to six hours and not to exceed 150 milligrams in 24 hours.

For allergic nasal symptoms, a 1% ephedrine-saline liquid has been used as a nose wash every 48 hours for four weeks.

For athletic performance enhancement, 1 milligram of ephedrine per kilogram body weight has been taken by mouth 90 minutes prior to exercise once weekly for four weeks.

For low blood pressure, 5-45 milligrams ephedrine has been injected into the vein or muscle.

For sexual arousal, 50 milligrams of ephedrine sulfate has been taken by mouth prior to exposure to erotic stimuli.

For weight loss, 2 grams of ephedra extract has been taken by mouth three times daily for eight weeks, 20-50 milligrams of ephedrine has been taken by mouth three times daily for 2-3 months.

Children (younger than 18 years)

Ephedrine is not recommended in children due to the risk of toxicity and death.

For asthma, 24-25 milligrams ephedrine or 0.65-2.1 milligrams ephedrine per kilogram has been taken by mouth every 6-8 hours for 1-8 weeks.

Safety
The U.S. Food and Drug Administration does not strictly regulate herbs and supplements. There is no guarantee of strength, purity or safety of products, and effects may vary. You should always read product labels. If you have a medical condition, or are taking other drugs, herbs, or supplements, you should speak with a qualified healthcare provider before starting a new therapy. Consult a healthcare provider immediately if you experience side effects.

Allergies

Avoid in people with a known allergy or sensitivity to ephedra, ephedrine, or pseudoephedrine (Sudafed®). Signs of allergy may include rash, itching, or red, flaking skin.

Side Effects and Warnings

The U.S. Food and Drug Administration (FDA) has collected more than 800 reports of serious toxicity, including more than 22 deaths. The U.S. Federal Government has banned the sale of ephedra in the United States since 2004.

Ephedra may affect blood sugar levels. Caution is advised when using medications that may also affect blood sugar. People taking drugs for diabetes by mouth or insulin should be monitored closely by a qualified healthcare professional, including a pharmacist. Medication adjustments may be necessary.

Ephedra may cause high blood pressure. Caution is advised in people taking drugs that affect blood pressure.

Use cautiously in people sensitive to stimulants or in combination with other known stimulant agents (e.g. coffee).

Use cautiously in people with kidney, thyroid, liver, or peptic ulcer disease.

Use cautiously in people with heart disease, such as structural heart disease, irregular heart rhythms, clogged arteries, high blood pressure, stroke, or in those taking agents for the heart.

Use cautiously in people with glaucoma, problems with the stomach or intestines, or seizure disorders.

Use cautiously in people with depression, anxiety disorders, anorexia/bulimia, a history of suicidal ideation, or previous use of monoamine oxidase inhibitor (MAOI) anti-depressants.

Use cautiously in people that have difficulty urinating or have an enlarged prostate.

Avoid use during major medical procedures (such as surgery), as ephedra may decrease effectiveness of anesthetics. Discontinue use at least one week prior to major surgery or other procedures.

Avoid using doses higher than suggested or using for a long duration (over seven days), due to risk of toxicity.

Avoid use in children due to risk of toxicity and death.

Avoid use during pregnancy or breastfeeding since ephedra may pass into breast milk.

Avoid in people with known allergy or sensitivity to ephedra or its parts.

Ephedra may raise blood pressure. Caution is advised in people taking drugs that affect blood pressure.

Ephedra may lower blood sugar levels, although ephedra-caffeine combinations may increase blood sugar. Caution is advised when using medications that may also alter blood sugar. Patients taking drugs for diabetes by mouth or insulin should be monitored closely by a qualified healthcare provider. Medication adjustments may be necessary.

Ephedra may interfere with the way the body processes certain drugs using the liver's "cytochrome P450" enzyme system. As a result, the levels of these drugs may be altered in the blood, and may cause altered effects or potentially serious adverse reactions. People using any medications should check the package insert, and speak with a qualified healthcare professional, including a pharmacist, about possible interactions.

Ephedra may raise blood pressure. Caution is advised in people taking herbs or supplements that affect blood pressure.

Ephedra may lower blood sugar levels, although ephedra-caffeine combinations may increase blood sugar. Caution is advised when using herbs and supplements that may also alter blood sugar. Blood glucose levels may require monitoring, and doses may need adjustment.

Ephedra may interfere with the way the body processes certain herbs or supplements using the liver's "cytochrome P450" enzyme system. As a result, the levels of other herbs or supplements may be altered in the blood. It may also alter the effects that other herbs or supplements possibly have on the P450 system.

Thomas JE, Munir JA, McIntyre PZ, et al. STEMI in a 24-year-old man after use of a synephrine-containing dietary supplement: a case report and review of the literature. Tex.Heart Inst.J. 2009;36(6):586-590.

The information in this monograph is intended for informational purposes only, and is meant to help users better understand health concerns. Information is based on review of scientific research data, historical practice patterns, and clinical experience. This information should not be interpreted as specific medical advice. Users should consult with a qualified healthcare provider for specific questions regarding therapies, diagnosis and/or health conditions, prior to making therapeutic decisions.